TriangleNCT04194944 · OUTCOME
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline through Disease Progression or Death Up to 31 Months
What was measured
ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm.
Analysis population: ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment.
Groups in this outcome
Selpercatinib (TRT A)
160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
Pemetrexed and Platinum With Pembrolizumab (TRT B)
Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin AUC 5 (maximum dose 750 mg) IV or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
| Group | Source count |
|---|---|
| Selpercatinib (TRT A) | 129 |
| Pemetrexed and Platinum With Pembrolizumab (TRT B) | 83 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Selpercatinib (TRT A) | 83.7 | Not reported | 76.2 | 89.6 | Not reported |
| Pemetrexed and Platinum With Pembrolizumab (TRT B) | 65.1 | Not reported | 53.8 | 75.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.1
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0028
- param Type
- Odds Ratio (OR)
- param Value
- 2.7
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.1
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0028
- param Type
- Odds Ratio (OR)
- param Value
- 2.7
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 76.2
- upper Limit
- 89.6
- value
- 83.7
- group Id
- OG001
- lower Limit
- 53.8
- upper Limit
- 75.2
- value
- 65.1
- denoms
- counts
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 83
- units
- Participants
- description
- ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
- id
- OG000
- title
- Selpercatinib (TRT A)
- description
- Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin AUC 5 (maximum dose 750 mg) IV or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
- id
- OG001
- title
- Pemetrexed and Platinum With Pembrolizumab (TRT B)
- param Type
- NUMBER
- population Description
- ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment.
- reporting Status
- POSTED
- time Frame
- Baseline through Disease Progression or Death Up to 31 Months
- title
- Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice